RecruitingPhase 3NCT07011719

Study of Casdatifan and Cabozantinib Versus Placebo and Cabozantinib in Patients With Advanced Clear Cell Renal Cell Carcinoma

A Randomized, Double-Blind, Active-Control, Multicenter Phase 3 Trial of Casdatifan and Cabozantinib Versus Placebo and Cabozantinib in Patients With Advanced Clear Cell Renal Cell Carcinoma

Sponsor

Arcus Biosciences, Inc.

Enrollment

720 participants

Start Date

Sep 8, 2025

Study Type

INTERVENTIONAL

Conditions

Metastatic Clear Cell Renal Cell Carcinoma Advanced Clear Cell Renal Cell Carcinoma

Summary

The purpose of the study is to evaluate the progression-free survival (PFS) of casdatifan versus placebo when each is given in combination with cabozantinib in adult patients with confirmed advanced or metastatic clear cell Renal Cell Carcinoma who have experienced progression on or after prior anti-PD-1 or anti-PD-L1 immunotherapy.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing whether adding casdatifan (a drug that cuts off the oxygen supply tumors need to grow) to cabozantinib (an existing standard targeted therapy) works better than cabozantinib alone for patients with advanced clear cell kidney cancer. **You may be eligible if...** - You have advanced kidney cancer that cannot be surgically removed, specifically the clear cell type - You have at least one measurable tumor on a CT or MRI scan - You are in good physical condition (Karnofsky score 80% or above) - Women of childbearing potential must have a negative pregnancy test **You may NOT be eligible if...** - You have received prior treatment with cabozantinib or another specific type of targeted therapy for kidney cancer - You have active brain metastases - You have significant heart or blood pressure problems - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCasdatifan

Administered as specified in the treatment arm

DRUGCabozantinib

Administered as specified in the treatment arm

DRUGPlacebo

Administered as specified in the treatment arm

Locations(118)

Research Site

Gilbert, Arizona, United States

Research Site

Goodyear, Arizona, United States

Research Site

Phoenix, Arizona, United States

Research Site

Duarte, California, United States

Research Site

La Jolla, California, United States

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Los Angeles, California, United States

Research Site

Sacramento, California, United States

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San Diego, California, United States

Research Site

New Haven, Connecticut, United States

Research Site

Jacksonville, Florida, United States

Research Site

Miami, Florida, United States

Research Site

Orlando, Florida, United States

Research Site

Atlanta, Georgia, United States

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Atlanta, Georgia, United States

Research Site

Newnan, Georgia, United States

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Zion, Illinois, United States

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Indianapolis, Indiana, United States

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Louisville, Kentucky, United States

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Jefferson, Louisiana, United States

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Baltimore, Maryland, United States

Research Site

Boston, Massachusetts, United States

Research Site

Boston, Massachusetts, United States

Research Site

Rochester, Minnesota, United States

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St Louis, Missouri, United States

Research Site

Omaha, Nebraska, United States

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New Brunswick, New Jersey, United States

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Buffalo, New York, United States

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Rochester, New York, United States

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Chapel Hill, North Carolina, United States

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Cleveland, Ohio, United States

Research Site

Portland, Oregon, United States

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Monroeville, Pennsylvania, United States

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Charleston, South Carolina, United States

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Nashville, Tennessee, United States

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Nashville, Tennessee, United States

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Dallas, Texas, United States

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Lubbock, Texas, United States

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Salt Lake City, Utah, United States

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Charlottesville, Virginia, United States

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Seattle, Washington, United States

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Chermside, Australia

Research Site

Elizabeth Vale, Australia

Research Site

Frankston, Australia

Research Site

Heidelberg, Australia

Research Site

Hobart, Australia

Research Site

Kurralta Park, Australia

Research Site

Subiaco, Australia

Research Site

Westmead, Australia

Research Site

Montreal, Canada

Research Site

Sherbrooke, Canada

Research Site

Toronto, Canada

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Brno-střed, Czechia

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Prague, Czechia

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Angers, France

Research Site

Brest, France

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Caen, France

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Montpellier, France

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Paris, France

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Poitiers, France

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Rennes, France

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Strasbourg, France

Research Site

Villejuif, France

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Berlin, Germany

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Dresden, Germany

Research Site

Frankfurt, Germany

Research Site

Freiburg im Breisgau, Germany

Research Site

Halle, Germany

Research Site

Hanover, Germany

Research Site

Marburg, Germany

Research Site

Rostock, Germany

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Milan, Italy

Research Site

Terni, Italy

Research Site

Verona, Italy

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Akita, Japan

Research Site

Kobe, Japan

Research Site

Matsuyama, Japan

Research Site

Maastricht, Netherlands

Research Site

Nijmegen, Netherlands

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Rotterdam, Netherlands

Research Site

Utrecht, Netherlands

Research Site

Zwolle, Netherlands

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Auckland, New Zealand

Research Site

Christchurch, New Zealand

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Hamilton, New Zealand

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Rotorua, New Zealand

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Krakow, Poland

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Otwock, Poland

Research Site

Poznan, Poland

Research Site

Rzeszów, Poland

Research Site

Skorzewo, Poland

Research Site

Tomaszów Mazowiecki, Poland

Research Site

Craiova, Romania

Research Site

Suceava, Romania

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Timișoara, Romania

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Busan, South Korea

Research Site

Daejeon, South Korea

Research Site

Goyang, South Korea

Research Site

Seongnam, South Korea

Research Site

Seoul, South Korea

Research Site

Suwon, South Korea

Research Site

Barcelona, Spain

Research Site

Córdoba, Spain

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Madrid, Spain

Research Site

Málaga, Spain

Research Site

Santander, Spain

Research Site

Seville, Spain

Research Site

Vigo, Spain

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Cambridge, United Kingdom

Research Site

Cottingham, United Kingdom

Research Site

Exeter, United Kingdom

Research Site

Glasgow, United Kingdom

Research Site

Leeds, United Kingdom

Research Site

London, United Kingdom

Research Site

Manchester, United Kingdom

Research Site

Preston, United Kingdom

Research Site

Southampton, United Kingdom

Research Site

Sutton, United Kingdom

Research Site

Truro, United Kingdom

View Full Details on ClinicalTrials.gov

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NCT07011719

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